CE Mark Odds, page-107

I think the difference is this - n = 1103
The medical industry is full of great results from small initial trials that fail when ramped up to meaningful numbers.

Bruce (SRX) had some spectacular results in his first trial, and the PDA was granted based on that. I think he got lucky and probably these days a PDA would not be granted on such low numbers.

If OCL can run a 1000 pt trial and still show a substantial improvement over other methods then your logic would be good.

I concur with Whytee inasmuch as I'm not trying to bag you or OSL, just trying to put out a balanced view from many years of pain and disappointment as a very long term SRX holder. Came good in the end, but it was not an easy ride especially as all the major trials 'failed' to achieve their primary objectives.

I do wish OSL all the best, but the history of the process, pre OSL, is a worry.